To study and evaluate the plasma concentration-time curves in health young women of free EPA and DHA, as well as those present in a fish oil food supplement (predominantly esterified to glycerol and/or as ethyl-esters) of their esters, following an…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
voedingsonderzoek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study and evaluate parameter is the plasma-time curve of free and
esterified EPa and DHA. This will be studied using descriptive kinetics
(maximum peak height (Cmax), time-to-peak (Tmax), and area-under-the-curve
(AUC)).
Secondary outcome
The secondary study parameter is the plasma-time curve of satiety hormones
GLP-1, PYY and CCK.
Background summary
Adequate intake of the omega-3 poly-unsaturated fatty acids docosahexaenoic
acid (DHA) and eicosapentaenoic acid (EPA), two fatty acids naturally occurring
in oily fish and other marine life, is associated with positive health effects.
Recently, a novel molecular form of EPA and DHA has been developed in which the
fatty acids are present as their lysine salts. This results in a solid form
which offers a number of advantages including greater stability of EPA and DHA,
as well as other technological benefits for their application in supplements or
other food products. Furthermore, it is hypothesized that DHA and EPA salts are
more rapidly, and perhaps more readily, absorbed compared to ethyl-esters or
triglycerides, as the free fatty acids are already released from the salts in
the acid environment of the stomach and no hydrolyses is needed. Although this
new form has recently been granted GRAS status by the FDA (based on
bio-equivalence considerations determined in vitro), its oral bio-availability
and plasma kinetics in humans has not been studied in detail yet.
Study objective
To study and evaluate the plasma concentration-time curves in health young
women of free EPA and DHA, as well as those present in a fish oil food
supplement (predominantly esterified to glycerol and/or as ethyl-esters) of
their esters, following an oral dose of 1400mg of a mixture containing DHA and
EPA lysine-salt (AvailOMTM), compared to 1400mg of a mixture of DHA and EPA
present as in a commercially available fish oil food supplement (LUCOVITAAL,
Puur Koudwater Omega 3 Visolie).
Study design
This study will have a cross-over design with two test periods of 48 hours
Intervention
Orale dose of EPA en DHA lysine salts or vis oil food supplementen (containing
EPA en DHA).
Study burden and risks
Consumption of EPA / DHA, either as glycerol-esters, ethyl-esters (e.g. the
medicinal product OmacorR), phospholipids (predominantly present in algae oils)
or in their free carboxylic form (EpanovaR) is common in humans and considered
to deliver health benefits. In the new salt formulation studied here, the
counter ion is lysine, which is an amino-acid that is abundantly present in the
diet and the human body. The test product has received an FDA no objection
letter. It is conceivable and supported by in vitro studies involving digestion
models that dissociation of the salt will rapidly occur in the stomach and that
fatty acids will become available for absorption starting from the proximal
site of the GI tract (duodenum). Compared to some forms of n-3 fatty acids, in
particular the esters, some differences in absorption kinetics might be
envisaged, since the latter ones require hydrolysis by lipases in the
gastro-intestinal tract. Furthermore, due to interactions with nutrient-sensing
receptors at other than usual locations, a different time-profile of satiety
hormones might result. The product has been designed to formulate omega-3
preparations with improved properties. Participants contribute to scientific
research and they will receive a financial compensation of ¤500,- when
completing the whole study. The placement of venous catheters and blood
sampling will lead to mild discomfort. The ingestion of the two preparations
might lead to side effects, among which gastrointestinal abnormalities (e.g.
burping). Lastly, the overnight stay at our research facilities will be a small
burden.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
* BMI between 18.5 and 25 kg/m2
* Age is between 18 and 28 years
* Good general health
* Female
* Veins suitable for blood sampling
Exclusion criteria
* Current diseases
* Any gastrointestinal conditions/diseases within the 3 months prior to the intervention
* Haemoglobin (Hb) level < 7.5 mmol/L
* Use of medication two months before and during the intervention, except for oral contraceptives and occasional use of NSAID (<1 NSAID per week average).
* (If applicable) In case of using contraceptives, not willing to delay the break between two packets of the conception pill during which a woman gets her period during the study period.
* Reported weight loss or weight gain of > 2 kg in the month prior to the intervention
* Use of omega-3 or fish oil supplements, 3 weeks before-, or during the intervention.
* Not willing to eat fish oil products or animal products
* Allergies to (shell)fish or soy products.
* Allergies to gluten or milk product.
* Following a certain diet
* (History of) drug abuse, in this case meaning >1 x per month use of recreational drugs
* Smoking
* Alcohol consumption of >10 standardised glasses per week.
* Recent or planned blood donation (<4 month prior to first study day or during intervention)
* Have been pregnant or breastfeeding in the last 6 months, or plan to become pregnant during the study
* Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
* Current and within 1 month of participation in other scientific research (apart from EetWeetMeet)
* Not having a general practitioner
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63619.081.18 |